Anti-diarrheal
- Product NDC
- 50844-375
- 11-digit product format
- 508440375
- Labeler code
- 50844
- Product ID
- 50844-375_132bccda-cebc-4c3f-a6df-0ea613564a93
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loperamide HCl
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- L.N.K. International, Inc.
- Application
- ANDA076497
- Marketing category
- ANDA
- Marketing start
- 2005-05-03
- Substance
- LOPERAMIDE HYDROCHLORIDE
- Active strength
- 2 mg/1
- Pharmacologic classes
- Opioid Agonist [EPC], Opioid Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Anti-diarrheal
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LOPERAMIDE HYDROCHLORIDE | 2 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 77TI35393C |
| Rxcui | 978010 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| LOPERAMIDE HYDROCHLORIDE | ACTIVE INGREDIENT | 77TI35393C | ANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [L.N.K. INTERNATIONAL, INC.] | 6 | |
| LOPERAMIDE | ACTIVE MOIETY | 6X9OC3H4II | ANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [L.N.K. INTERNATIONAL, INC.] | 6 | |
| CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE | INACTIVE INGREDIENT | O7TSZ97GEP | ANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [L.N.K. INTERNATIONAL, INC.] | 6 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [L.N.K. INTERNATIONAL, INC.] | 6 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | ANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [L.N.K. INTERNATIONAL, INC.] | 6 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | ANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [L.N.K. INTERNATIONAL, INC.] | 6 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [L.N.K. INTERNATIONAL, INC.] | 6 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [L.N.K. INTERNATIONAL, INC.] | 6 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | ANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [L.N.K. INTERNATIONAL, INC.] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50844-375 | ANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [L.N.K. INTERNATIONAL, INC.] | 22 | Current NDC, Legacy NDC, 8 package rows | 20240727_e34f5bbc-e43c-a69e-e94d-ebc319518204.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50844-375-02 | 50844037502 | 3 BLISTER PACK in 1 CARTON (50844-375-02) / 4 TABLET in 1 BLISTER PACK | 3 blister pack | 2005-05-03 | 0000-00-00 | No | No | Current |
| 50844-375-08 | 50844037508 | 4 BLISTER PACK in 1 CARTON (50844-375-08) / 6 TABLET in 1 BLISTER PACK | 4 blister pack | 2005-05-03 | 0000-00-00 | No | No | Current |
| 50844-375-45 | 50844037545 | 1 BLISTER PACK in 1 CARTON (50844-375-45) / 6 TABLET in 1 BLISTER PACK | 1 blister pack | 2005-05-03 | 0000-00-00 | No | No | Current |
| 50844-375-95 | 50844037595 | 2 BLISTER PACK in 1 CARTON (50844-375-95) / 6 TABLET in 1 BLISTER PACK | 2 blister pack | 2005-05-03 | 0000-00-00 | No | No | Current |